RENNIE EXTRA

The usual dose is 2 tablets to be chewed. It should preferably be taken one hour after meals and before going to bed. An additional dose can also be taken in between in the case of heartburn. The maximum dose of 8 grams calcium carbonate (corresponding to 12 tablets) per day should not be exceeded and should not be taken continuously for longer than 2 weeks.

Only for use by adults and children over 12 years of age. As with all antacids, if symptoms persist despite 14 days of continuous therapy, diagnostic measures are strongly recommended in order to rule out a more serious disease. 4.

Immune System Disorders:

Hypersensitivity reactions have very rarely been reported. Clinical symptoms may include rash, pruritus, urticaria, angioedema dyspnea and anaphylaxis.

Metabolism and nutrition disorders:

Prolonged use of high doses may possibly result in hypermagnesaemia or hypercalcaemia and alkalosis (GI symptoms such as nausea and vomiting, fatigue, confusion, polyuria, polydypsia, dehydration), particularly in patients with impaired renal function.

Prolonged use of high doses of calcium carbonate with milk may lead to Burnett syndrome (milkalkali syndrome).

Gastrointestinal disorders:

Nausea, vomiting, stomach discomfort, constipation and diarrhoea may occur.

Musculoskeletal and Connective Tissue Disorders:

Muscular weakness may occur. 9): Gastrointestinal Disorders: Ageusia may occur in the context of milk-alkali syndrome.

General Disorders and Administration Site Conditions:

Calcinosis and asthenia may occur in the context of milk-alkali syndrome.

Nervous System Disorders:

Headache may occur in the context of milk-alkali syndrome.

Renal and Urinary Disorders:

Azotemia may occur in the context of milk-alkali syndrome. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Prolonged use should be avoided. If the symptoms persist or only partly disappear, further medical advice should be sought. As with other antacids, Rennie Extra tablets may mask a malignancy in the stomach. Rennie Extra tablets should not be used in the following cases:  Hypercalciuria  In general, caution should be exercised in patients with impaired renal function.

 If Rennie Extra tablets are used in such patients, plasma concentrations of calcium, phosphate and magnesium should be monitored regularly. In general calcium containing antacids should be carefully administered in patients with constipation, haemorrhoids and sarcoidosis.

Prolonged use of high doses may result in undesirable side-effects such as hypercalcaemia, magnesaemia and the milk alkali syndrome, particularly in patients suffering from renal insufficiency. The product should not be taken with large amounts of milk or dairy products.

Prolonged use increases the risk of formation of renal calculi. In the literature a possible relationship between calcium carbonate and appendicitis, gastrointestinal haemorrhage, intestinal blockage, or oedema has been reported in single cases.

7% of the WHO recommended maximum daily intake of 2g sodium for an adult. 22 mg glucose (including from dextrates) per tablet, which should be taken into account in patients with diabetes. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

If symptoms persist after fourteen days, the clinical situation should be reviewed by a healthcare professional.

 Severe renal insufficiency  hypercalcaemia and/or conditions resulting in hypercalcaemia  pre-existing hypophosphataemia  nephrolithiasis due to calculi containing calcium deposits  hypersensitivity to the active substances or to any of the excipients.